The Efficacy of the Bladder EpiCheck for Detection of Recurrent Urothelial Cell Carcinoma

Nucleix Ltd.680 enrolled

Overview

Clinical trial to determine the efficacy (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer This is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent Urothelial Cell Carcinoma in patients with a history of bladder cancer undergoing surveillance.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

680

Conditions

Bladder Cancer

Interventions

Bladder EpiCheck Urine TestDEVICE

Cystoscopy and pathologyPROCEDURE

Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals. * Has had all urothelial cell carcinoma tumor resected within the past 12 months * Has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed) * Able to provide legally effective informed consent * Able to produce 45mL of urine Exclusion Criteria: * Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma

Locations (11)

The Urology Center of Colorado

Denver, Colorado, United States

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

Michigan Institute of Urology, P.C.

Troy, Michigan, United States

Outcomes

Primary Outcomes

Specificity of Bladder EpiCheck Urine Test Kit (the proportion of negatives that are correctly identified as such by the gold standard)

Time frame: Day 1

Sensitivity of Bladder EpiCheck Urine Test Kit (The proportion of positives that are correctly identified as such by the gold standard)

Time frame: Day 1

Data from ClinicalTrials.gov

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